Design issues in global mental health trials in low-resource settings

2015 ◽  
Author(s):  
Helen Weiss
Keyword(s):  
Mental Health ◽  
Gold Standard ◽  
Trial Design ◽  
Global Mental Health ◽  
Stepped Wedge ◽  
Randomized Controlled ◽  
Superiority Trial ◽  
Definition Of ◽  
Preference Trial ◽  
Size Estimates

In this chapter we outline the key principles in design and analysis of trials for mental health. The chapter focuses on randomized controlled trials as these are the gold-standard trial design, which minimizes confounding due to other factors and enables us to draw conclusions about the effectiveness of the intervention. Other key principles of trial design discussed in the chapter include methods to develop a clearly stated, testable research hypothesis, definition of well-defined outcomes, appropriate choice of the control condition, masking of providers and participants where possible, realistic sample size estimates, and appropriate data monitoring and statistical analysis plans. The chapter also outlines alternatives to the parallel arm superiority trial design, such as equivalence and non-inferiority trials, cross-over, stepped wedge, fixed adaptive, and patient preference trial designs.

scholarly journals A regional systems intervention for suicide prevention in the Netherlands (SUPREMOCOL): study protocol with a stepped wedge trial design

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Emma Hofstra ◽  
Iman Elfeddali ◽  
Margot Metz ◽  
Marjan Bakker ◽  
Jacobus J. de Jong ◽  
...  
Keyword(s):  
Mental Health ◽  
Suicidal Ideation ◽  
The Netherlands ◽  
Suicide Prevention ◽  
Study Protocol ◽  
Collaborative Care ◽  
Trial Design ◽  
Stepped Wedge ◽  
Health Institutions ◽  
Stepped Wedge Trial

Abstract Background In the Netherlands, suicide rates showed a sharp incline and this pertains particularly to the province of Noord-Brabant, one of the southern provinces in the Netherlands. This calls for a regional suicide prevention effort. Methods/design Study protocol. A regional suicide prevention systems intervention is implemented and evaluated by a stepped wedge trial design in five specialist mental health institutions and their adherent chain partners. Our system intervention is called SUPREMOCOL, which stands for Suicide Prevention by Monitoring and Collaborative Care, and focuses on four pillars: 1) recognition of people at risk for suicide by the development and implementation of a monitoring system with decision aid, 2) swift access to specialist care of people at risk, 3) positioning nurse care managers for collaborative care case management, and 4) 12 months telephone follow up. Eligible patients are persons attempting suicide or expressing suicidal ideation. Primary outcome is number of completed suicides, as reported by Statistics Netherlands and regional Public Health Institutes. Secondary outcome is number of attempted suicides, as reported by the regional ambulance transport and police. Suicidal ideation of persons registered in the monitoring system will, be assessed by the PHQ-9 and SIDAS questionnaires at baseline and 3, 6, 9 and 12 months after registration, and used as exploratory process measure. The impact of the intervention will be evaluated by means of the RE-AIM dimensions reach, efficacy, adoption, implementation, and maintenance. Intervention integrity will be assessed and taken into account in the analysis. Discussion The present manuscript presents the design and development of the SUPREMOCOL study. The ultimate goal is to lower the completed suicides rate by 20%, compared to the control period and compared to other provinces in the Netherlands. Moreover, our goal is to provide specialist mental health institutions and chain partners with a sustainable and adoptable intervention for suicide prevention. Trial registration Netherlands Trial Register under registration number NL6935 (5 April 2018). This is the first version of the study protocol (September 2019).

scholarly journals Promotion, prevention and treatment interventions for mental health in low- and middle-income countries through a task-shifting approach

2020 ◽  
Vol 29 ◽  
Author(s):  
Marianna Purgato ◽  
Eleonora Uphoff ◽  
Rakesh Singh ◽  
Ambika Thapa Pachya ◽  
Jibril Abdulmalik ◽  
...  
Keyword(s):  
Mental Health ◽  
At Risk ◽  
Global Mental Health ◽  
Task Shifting ◽  
Treatment Interventions ◽  
Middle Income ◽  
Middle Income Countries ◽  
Prevention And Treatment ◽  
Prevention Interventions ◽  
Definition Of

Abstract Recently, mental health and ill health have been reframed to be seen as a continuum from health to ill health, through the stages of being asymptomatic ‘at risk’, to experiencing ‘mental distress’, ‘sub-syndromal symptoms’ and finally ‘mental disorders’. This new conceptualisation emphasised the importance of mental health promotion and prevention interventions, aimed at reducing the likelihood of future disorders with the general population or with people who are identified as being at risk of a disorder. This concept generated discussion on the distinction between prevention and treatment interventions, especially for those mental health conditions which lie between psychological distress and a formal psychiatric diagnosis. The present editorial aims to clarify the definition of promotion, prevention and treatment interventions delivered through a task-shifting approach according to a global mental health perspective.

scholarly journals The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled treatment trial with an embedded stepped-wedge cluster randomized controlled recruitment trial

2018 ◽  
Author(s):  
Rachana Parikh ◽  
Rooplata Sahu ◽  
Christopher G Fairburn ◽  
Bruce Chorpita ◽  
Pim Cuijpers ◽  
...  
Keyword(s):  
Mental Health ◽  
Problem Solving ◽  
Controlled Trial ◽  
Adolescent Mental Health ◽  
New Delhi ◽  
Stepped Wedge ◽  
Mental Health Symptoms ◽  
Health Symptoms ◽  
Randomized Controlled ◽  
School Based

Abstract Background Conduct, anxiety and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention to improve mental health symptoms and recovery rates for school-going adolescents in India. The protocol also tests the effects of a classroom-based sensitization intervention on the demand for counselling services in an embedded recruitment trial. Methods We will conduct a two-arm individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9-12 with persistent, elevated mental health symptoms and associated impact. Participants will receive either a brief problem-solving intervention delivered over 3 weeks by lay counsellors (intervention), or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health symptoms and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported impact of mental health difficulties, perceived stress, mental wellbeing and clinical remission, as well as parent-reported adolescent mental health symptoms and impact scores, will be assessed at 6 and 12 weeks post-randomization. Parallel process evaluation, including estimations of the costs of delivering the interventions, will be conducted. An embedded recruitment trial will apply a stepped-wedge, cluster (class)-randomized controlled design in 70 classes across the six schools. This will evaluate the added impact of a classroom-based sensitization intervention over school-level recruitment sensitization activities on the primary outcome of referral rate (number of referred students as a proportion of the total sampling frame in each arm). Secondary outcomes will be the proportion of referrals eligible to participate in the host trial, proportion of self-generated referrals, and severity and pattern of symptoms across the arms. Power calculations were undertaken separately for each trial. A detailed statistical analysis plan will be developed separately for each trial prior to unbinding. Discussion Both trials were initiated on 20 August 2018. A single research protocol for both trials offers a resource-efficient methodology for testing the effectiveness of linked procedures to enhance uptake and outcomes of a school-based psychological intervention for adolescents. Trial registration: Both trials are registered prospectively with the National Institute of Health registry (www.clinicaltrials.gov, registration numbers NCT03633916 and NCT03630471) Keywords: mental health, problem-solving, psychological treatment, stepped-wedge trial, adolescents, schools, randomized controlled trial, low- and middle-income countries, India.

scholarly journals Atmiyata, a community led intervention to address common mental disorders: Study protocol for a stepped wedge cluster randomized controlled trial in rural Gujarat, India

2019 ◽  
Author(s):  
Kaustubh Joag ◽  
Jasmine Kalha ◽  
Deepa Pandit ◽  
Susmita Chatterjee ◽  
Sadhvi Krishnamoorthy ◽  
...  
Keyword(s):  
Mental Health ◽  
Common Mental Disorders ◽  
Controlled Trial ◽  
Mixed Effects ◽  
Stepped Wedge ◽  
Linear Mixed Effects ◽  
Lay Health Worker ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact

Abstract Background: While lay-health worker models for mental health care have proven to be effective in controlled trials, there is limited evidence on the effectiveness and scalability of these models in rural communities in low- and middle-income countries (LMICs). Atmiyata is a rural community-led intervention using local community volunteers, called Champions, to identify and provide evidence-based counselling for persons with common mental disorders (CMD) as part of a package of community-based interventions for mental health. Methods: The impact of the Atmiyata intervention is evaluated through a stepped wedge cluster randomized controlled trial (SW-CRCT) with a nested economic evaluation. The trial spans across 10 sub-blocks (645 villages) in Mehsana district with 1.52 million rural adult population. There are 56Primary Health Centers (PHCs) in Mehsana district and villages covered under these PHCs are equally divided into four groups of clusters of 14 PHCs each, and the intervention is rolled out in a staggered manner in these groups of villages at an interval of 5 months. The primary outcome is symptomatic improvement measured through the GHQ-12 at 3-month follow-up. Secondary outcomes include: quality of life using the EURO-QoL (EQ- 5D), symptom improvement measured by the Self-Reporting Questionnaire-20 (SRQ-20), functioning using the WHO Disability Assessment Scale (WHO-DAS-12), depression symptoms using the Patient Health Questionnaire, (PHQ-9), anxiety symptoms using Generalized Anxiety Disorder Questionnaire, (GAD-7) and social participation using the Social Participation Scale (SPS). Generalized linear mixed effects model are employed for binary outcomes and linear mixed effects models for continuous outcomes. A Return on investment (ROI) analysis of the intervention will be conducted to understand whether the intervention generates any return on financial investments made into the project. Discussion: Stepped wedge designs are progressively being used to evaluate real-life effectiveness of interventions. To the best of our knowledge, this is the first SW-CRCT in a LMIC evaluating the impact of implementation of a psychosocial mental health intervention. The results of this study will contribute to the evidence on scaling-up lay health worker models for mental health interventions and contribute to the SW-CRCT literature in LMICs.

The importance of trials for global mental health

2015 ◽  
Author(s):  
Graham Thornicroft ◽  
Vikram Patel
Keyword(s):  
Mental Health ◽  
Global Mental Health ◽  
Mental Health Research ◽  
Middle Income ◽  
Middle Income Countries ◽  
Randomized Controlled ◽  
History Of ◽  
Research Continuum ◽  
Key Terms

This chapter sets the scene for the book as a whole by defining key terms, giving a brief history of randomized controlled trails (RCTs) in mental health research, explaining why RCTs can produce strong forms of evidence, and by locating trials within the translational research continuum. The authors describe criteria with which to judge the quality of pragmatic RCTs. Finally the authors discuss how the results of trials can be used to inform policy, investment, and service delivery decisions in low and middle income countries.

Global mental health, autonomy and medical paternalism: reconstructing the ‘French ethical tradition’ in psychiatry

2017 ◽  
Vol 28 (3) ◽  
pp. 326-343 ◽  
Author(s):  
Tiago Pires Marques
Keyword(s):  
Mental Health ◽  
Ethical Decision Making ◽  
Global Mental Health ◽  
Global Scale ◽  
Deontological Ethics ◽  
American Model ◽  
History Of ◽  
Anglo American ◽  
Definition Of ◽  
Ethical Reflections

In the last few decades, the definition of deontological ethics, a well-identified ethical territory in psychiatry, has been the object of increasing concerns. This has been the case in France, where claims of a specific ethical tradition in psychiatry have accompanied the institutionalization of psychiatric ethics and the perceived globalization of an Anglo-American model of mental health care. This study traces the history of the ‘French ethical tradition in psychiatry’ and its relationship with establishing institutional spaces for ethical decision-making. The ‘ethical tradition’ thus conceived proves to be functional in terms of preserving the threatened identity of French psychiatry. Nevertheless, this movement also pinpoints impasses that transcend the French context and may provide valuable resources for ethical reflections on mental health on a global scale.

scholarly journals Atmiyata, a community led intervention to address common mental disorders: Study protocol for a stepped wedge cluster randomized controlled trial in rural Gujarat, India

2019 ◽  
Author(s):  
Kaustubh Joag ◽  
Jasmine Kalha ◽  
Deepa Pandit ◽  
Susmita Chatterjee ◽  
Sadhvi Krishnamoorthy ◽  
...  
Keyword(s):  
Mental Health ◽  
Common Mental Disorders ◽  
Controlled Trial ◽  
Mixed Effects ◽  
Stepped Wedge ◽  
Linear Mixed Effects ◽  
Lay Health Worker ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact

Abstract Background While lay-health worker models for mental health care have proven to be effective in controlled trials, there is limited evidence on the effectiveness and scalability of these models in rural communities in low- and middle-income countries (LMICs). Atmiyata is a rural community-led intervention using local community volunteers, called Champions, to identify and provide evidence-based counselling for persons with common mental disorders (CMD) as part of a package of community-based interventions for mental health. Methods The impact of the Atmiyata intervention is evaluated through a stepped wedge cluster randomized controlled trial (SW-CRCT) with a nested economic evaluation. The trial spans across 10 sub-blocks (645 villages) in Mehsana district with 1.52 million rural adult population. 56 PHCs in Mehsana district are equally divided into four clusters of 14 PHCs each, and the intervention is rolled out in cluster in a staggered manner at an interval of 5 months. The primary outcome is symptomatic improvement measured through the GHQ-12 at 3-month follow-up. Secondary outcomes include: quality of life using the EURO-QoL (EQ- 5D), symptom improvement measured by the Self-reporting questionnaire-20 (SRQ-20), functioning using the WHO Disability Assessment Scale (WHO-DAS-12), depression symptoms (Patient Health Questionnaire, PHQ-9)) and anxiety symptoms (Generalized Anxiety Disorder Questionnaire, GAD-7) and social participation using the Social Participation Scale (SPS). Linear mixed effects models are employed for continuous outcomes and generalized linear mixed effects model for binary outcomes. Discussion Stepped wedge designs are progressively being used to evaluate real-life effectiveness of interventions. To the best of our knowledge, this is the first SW-CRCT in a LMIC evaluating the impact of the implementation of a mental health intervention. The results of this study will contribute to the evidence on scaling-up lay health worker models for mental health interventions and contribute to the SW-CRCT literature in LMICs.

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